COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE

K061011 · Smith & Nephew, Inc. · HSX · Jul 11, 2006 · Orthopedic

Device Facts

• Record ID: K061011
• Device Name: COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE
• Applicant: Smith & Nephew, Inc.
• Product Code: HSX · Orthopedic
• Decision Date: Jul 11, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3520
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Competitor Unicondylar Tibial Baseplate Components are indicated for restoring either compartment of a knee that has been affected by the following: - Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or . avascular necrosis; - . correction of functional deformity; - 트 revision procedures where other treatments or devices have failed; and - treatment of fractures that are unmanageable using other techniques The baseplate components are single use only and are intended for implantation only with bone cement.

Device Story

Metal-backed tibial baseplate components for unicondylar knee arthroplasty; designed for use with specific articular inserts. Implantation performed by orthopedic surgeons in a clinical/surgical setting. Device functions as a mechanical prosthesis to restore knee joint function in patients with degenerative joint disease or fractures. Intended for cemented fixation only. Benefits include restoration of joint mobility and reduction of pain associated with knee pathology.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material similarities to legally marketed predicate devices.

Technological Characteristics

Metal-backed tibial baseplate components. Materials and design are based on the predicate Genesis Unicompartmental Knee System (K912735). Intended for cemented fixation. Single-use device.

Indications for Use

Indicated for patients requiring restoration of a knee compartment due to noninflammatory degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis), functional deformity, revision of failed prior treatments, or unmanageable fractures. For single use; must be implanted with bone cement.

Regulatory Classification

Identification

A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).

Predicate Devices

• Smith & Nephew Genesis Unicompartmental Knee System (K912735)

Reference Devices

• Smith & Nephew Unicondylar Femoral Component (K030301)

Submission Summary (Full Text)

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K061011 (pg 1 of 1)

## 510(K) Summary

## JUL 1 1 2006

## Smith & Nephew Competitor Unicondylar Tibial Baseplate Components

| SUBMITTER'S NAME: | Smith & Nephew, Inc., Orthopaedic Division |
|-----------------------------------|--------------------------------------------------------------------------------------------|
| SUBMITTER'S ADDRESS: | 1450 East Brooks Road, Memphis, TN 38116 |
| SUBMITTER'S TELEPHONE NUMBER: | 901-399-6707 |
| CONTACT PERSON: | Gino J. Rouss |
| DATE SUMMARY PREPARED: | April 10, 2006 |
| TRADE OR PROPRIETARY DEVICE NAME: | Smith & Nephew Competitor Unicondylar Tibial Baseplate Components |
| COMMON OR USUAL NAME: | Knee Prosthesis |
| CLASSIFICATION NAME: | Knee joint femorotibial metal/polymer non-constrained cemented prosthesis, 21 CFR 888.3520 |
| DEVICE CLASS: | Class II |
| PANEL CODE: | HSX Orthopedics Panel/87 |

#### A. INTENDED USE:

The Competitor Unicondylar Tibial Baseplate Components are indicated for restoring either compartment of a knee that has been affected by the following:

- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or . avascular necrosis;
- . correction of functional deformity;
- 트 revision procedures where other treatments or devices have failed; and
- treatment of fractures that are unmanageable using other techniques

The baseplate components are single use only and are intended for implantation only with bone cement.

#### B. DEVICE DESCRIPTION:

New unicondylar knee tibial baseplate components have been designed and developed by Smith & Nephew Orthopaedics. The subject devices are metal-backed tibial baseplates that are designed to be used with specific articular inserts. The overall designs of the components are based upon the existing Genesis Unicompartmental tibial implants subject of K912735.

#### C. SUBSTANTIAL EQUIVALENCE INFORMATION:

The Smith & Nephew Competitor Unicondylar Tibial Baseplate Components are similar to the following commercially available devices regarding design features, overall indications, and materials:

- · Smith & Nephew Genesis Unicompartmental Knee System (K912735)
- · Smith & Nephew Unicondylar Femoral Component (K030301)

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### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 1 1 2006

Smith & Nephew, Inc. Orthopaedic Division % Mr. Gino J. Rouss Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116

Re: K061011

Trade/Device Name: Competitor Unicondylar Tibial Baseplate Components Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSX Dated: April 10, 2006 Received: April 12, 2006

Dear Mr. Rouss:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Dr u and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, incl. Ast. A devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 -- Mr. Gino J. Rouss

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Buchun
to
Mark N. Melin

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known):

KO61011

Device Name: Competitor Unicondylar Tibial Baseplate Components

Indications for Use:

The Competitor Unicondylar Tibial Baseplate Components are indicated for restoring either compartment of a knee that has been affected by the following:

- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or . avascular necrosis;
- correction of functional deformity; ●
- revision procedures where other treatments or devices have failed; and .
- treatment of fractures that are unmanageable using other techniques ●

The baseplate components are for single use only and are intended for implantation only with bone cement.

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Division of General. Restorative. and Neurological Devices

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**510(k) Number** K061011